MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC.; GAMMA CAMERA

Device Problem Loss of Data (2903)

Patient Problem No Information (3190)

Event Date 05/21/2018

Event Type  malfunction  

Event Description

Acquisition computer spontaneously rebooted with 50 seconds remaining on a 90 minute acquisition.Data recovery was attempted with assistance from siemens.Was informed that the data was lost due to the computer rebooting during the acquisition.Certified nuclear medicine technologist (cnmt) was present during the dynamic acquisition.Registered technologist (rt) contacted siemens and the nuclear medicine supervisor to attempt data recovery.

• Type of Device: GAMMA CAMERA
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.; 810 innovation drive; knoxville TN 37932
• MDR Report Key: 8109841
• MDR Text Key: 128572877
• Report Number: 8109841
• Device Sequence Number: 1
• Product Code: IYX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/21/2018
• Event Location: Hospital
• Date Report to Manufacturer: 11/28/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/28/2018
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 20075 DA
• Patient Weight: 70